# K073705: Model TW SB, Scalp Vein Set; Model TW LB, Sterile Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Qiaopai Group Co., Ltd.
- Decided: Mar 24, 2008 after 84 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood. Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.

Source page: https://510kreport.com/device/K073705
Methodology: https://510kreport.com/methodology